Vytorin 10 mg/40 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VYTORIN 10 mg/20 mg tablets

VYTORIN 10 mg/40 mg tablets

Ezetimibe and simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What VYTORIN is and what it is used for
2. What you need to know before taking VYTORIN
3. How to take VYTORIN
4. Possible side effects
5. How to store VYTORIN
6. Contents of the pack and other information

1. What VYTORIN is and what it is used for

VYTORIN contains the active substances ezetimibe and simvastatin. VYTORIN is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides in the blood. In addition, VYTORIN increases levels of "good" cholesterol (HDL cholesterol).

VYTORIN works to reduce cholesterol in two ways. The active substance ezetimibe reduces the cholesterol absorbed through the digestive tract. The active substance simvastatin, which belongs to a group of medicines called "statins", inhibits the production of cholesterol made by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat in your blood that may increase the risk of heart disease.

VYTORIN is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

VYTORIN is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled by a statin alone,

• for whom treatment with a statin and ezetimibe in separate tablets has been used.

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; VYTORIN reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

VYTORIN does not help you to lose weight.

2. What you need to know before taking VYTORIN

Do not take VYTORIN if

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6. Package contents and other information),

• you currently have liver problems,

• you are pregnant or breastfeeding,

• you are taking medications containing one or more of the following active substances:

• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),

• erythromycin, clarithromycin, or telithromycin (used to treat infections),

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections),

• boceprevir or telaprevir (used to treat hepatitis C virus infection),

• nefazodone (used to treat depression),

• cobicistat,

• gemfibrozil (used to reduce cholesterol),

• cyclosporine (used in organ transplant patients),

• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and VYTORIN may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10/40 mg of VYTORIN if you are taking lomitapide (used to treat rare, inherited cholesterol disorders).

Consult your doctor if you are unsure whether your medication is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol or have ever had liver disease. VYTORIN may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking VYTORIN tablets for a short period of time,
• if you are of Asian descent, as you may require a different dose,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking VYTORIN and also if you develop any symptoms of liver problems while taking VYTORIN. This is to check how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with VYTORIN.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Talk to your doctor if you have a serious lung disease.

The combined use of VYTORIN and fibrates (certain cholesterol-lowering medicines) should be avoided, as the combination of VYTORIN and fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of VYTORIN, especially the 10/80 mg dose. The risk of muscle breakdown is also higher in certain patients. Inform your doctor in the following situations:

• if you have kidney problems,
• if you have thyroid problems,
• if you are over 65 years old,
• if you are female,
• if you have ever had muscle problems while taking cholesterol-lowering medicines called "statins" (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate),
• if you or close family members have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

• VYTORIN is not recommended for children under 10 years of age.

Taking VYTORIN with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine containing any of the following active substances. Taking VYTORIN with any of the following medicines may increase the risk of muscle problems (some of these are already listed in the section above “Do not take VYTORIN if”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart VYTORIN treatment. Using VYTORIN with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• cyclosporine (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus),
• medicines with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active substance such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS),
• antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat irregular heart rhythm),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat rare, inherited cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., VYTORIN). Your doctor may decide that you should temporarily stop taking VYTORIN,
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol),
• colchicine (used to treat gout).

As with the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription. In particular, inform your doctor if you are taking any of the following:

• medicines with an active substance to prevent blood clotting, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants),
• colestyramine (also used to reduce cholesterol), as it affects how VYTORIN works,
• fenofibrate (also used to reduce cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (an antiplatelet medicine).

You should also inform any doctor prescribing you a new medicine that you are taking VYTORIN.

Taking VYTORIN with food and drinks

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including VYTORIN. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take VYTORIN if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking VYTORIN, stop taking it immediately and inform your doctor. Do not take VYTORIN if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

VYTORIN is not expected to interfere with your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking VYTORIN.

VYTORIN contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

VYTORIN contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take VYTORIN

Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation.

The tablets do not have a score line and must not be divided.

Always follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• Before starting VYTORIN, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking VYTORIN.

Adults: the dose is 1 tablet of VYTORIN once daily by oral administration.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of VYTORIN once daily by oral administration (a maximum dose of 10 mg/40 mg once daily must not be exceeded).

The VYTORIN 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease complications who have not achieved their treatment goal with lower doses.

Take VYTORIN in the evening. You may take it with or without food.

If your doctor has prescribed VYTORIN together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must take VYTORIN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more VYTORIN than you should

• In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take VYTORIN

• Do not take a double dose to make up for missed doses. Take your usual dose of VYTORIN at the regular time.

If you stop taking VYTORIN

• Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them (see section 2. What you need to know before you start taking VYTORIN).

The following frequent adverse effects have been reported (may affect up to 1 in 10 people):

• muscle pain,
• increased liver function tests in blood laboratory analyses (transaminases) and/or muscle tests (CK).

The following uncommon adverse effects have been reported (may affect up to 1 in 100 people):

• increased liver function in blood tests; increased blood uric acid levels; prolonged blood clotting time; protein in urine; weight loss,
• dizziness; headache; tingling sensation,
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhoea; dry mouth; heartburn,
• rash; itching; urticaria,
• joint pain; pain, hypersensitivity, weakness or muscle spasms; neck pain; arm and leg pain; back pain,
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• sleep disorders; difficulty sleeping.

The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from the available data):

• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in people taking VYTORIN or medicines containing the active substances ezetimibe or simvastatin:

• low red blood cell count (anaemia), reduced blood cell count, which may cause bruising/bleeding (thrombocytopenia),
• numbness or weakness in arms and legs; memory impairment, memory loss, confusion,
• respiratory problems including persistent cough and/or difficulty breathing or fever,
• constipation,
• inflammation of the pancreas, often with severe abdominal pain,
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stools, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting),
• hair loss; red, raised rash, sometimes with target-like skin lesions (erythema multiforme),
• blurred vision and worsening of vision (may affect up to 1 in 1,000 people),
• skin rash or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• hypersensitivity reactions which may include: allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and require immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, atypical bruising, skin rashes and swelling, urticaria, skin sensitivity to sunlight, fever, hot flushes, breathing difficulties and general malaise, pseudolupus syndrome (including skin rash, joint disorders and effects on white blood cells). A very rare severe allergic reaction (may affect up to 1 in 10,000 people) causing difficulty breathing or dizziness, requiring immediate treatment (anaphylaxis), may occur,
• muscle pain, tenderness, weakness or cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture,
• gynaecomastia (enlargement of the breast in men) (may affect up to 1 in 10,000 people),
• decreased appetite,
• hot flushes; high blood pressure,
• pain,
• erectile dysfunction,
• depression,
• changes in certain blood tests of liver function.

The following additional adverse events have been reported with some statins:

• sleep disorders, including nightmares,
• sexual dysfunction,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness or weakness, which may not resolve after stopping treatment with VYTORIN (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VYTORIN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or container following [EXP].
• Do not store VYTORIN tablets above 30°C.

Blisters: Keep in the original packaging to protect from moisture and light.
Bottles: Keep bottles tightly closed to protect from moisture and light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of VYTORIN

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg or 40 mg of simvastatin.

The other components are: butyl hydroxyanisole, citric acid monohydrate, sodium croscarmellose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.

Appearance of the product and contents of the pack

VYTORIN tablets are capsule-shaped, white to off-white, with the code “312” on one side for VYTORIN 10 mg/20 mg tablets or “313” for VYTORIN 10 mg/40 mg tablets. The tablets do not have a breakline and must not be divided.

Pack sizes:

7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multiple pack containing 98 tablets (2 packs of 49), 100, or 300 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

or

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

or

Savio Industrial Srl.

Via Emilia, 21

27100 Pavia (PV)

Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following name:

VYTORIN in: Germany, Italy, Portugal and Spain.

Date of the most recent review of this leaflet: 04/2026.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)